# K132178: Mostdi Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Mostdi Innovations Sdn Bhd
- Decided: Apr 30, 2014 after 289 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K960026 (1996). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130140: Intra-Lock OP Dental Implant, Intra-Lock International (2013). Cleared while this submission was under review Summary page 2.
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 2.
- K121707: Lew Mdi O-Ball Collared Implant,, Park Dental Research Corp. (2012) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003). Our OCR of the scanned summary read K033106, FDA’s number for Captia HSV 2 Igg Type Specific Elisa Kit (Trinity Biotech USA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IMTEC Sendax MDI and MDI Plus”.

## Indications for use
The Mostdi - dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K132178
Methodology: https://510kreport.com/methodology